Calliditas is a clinical-stage biopharmaceutical company focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs.
Calliditas has developed a pipeline on orphan focused indications.
Calliditas read out positive topline data from a global Phase 3 study in 2020 and filed an NDA with the FDA in March 2021. If approved, Calliditas aims to commercialize its product in the United States on its own, whilst partnering ex- US. Calliditas submitted an MAA to the EMA in May 2021.
In 2020, Calliditas acquired the company Genkyotex and plans to initiate Phase 2/3 and Phase 2 studies in 2021.
Calliditas is led by an experienced and dedicated management team with an average of more than 15 years of prior experience in the pharmaceutical industry, including at leading companies such as GlaxoSmithKline, Pfizer and AstraZeneca. The board of directors includes highly qualified researchers, pharmaceutical sector executives and experts in drug development, corporate development and pharmaceutical commercialization. Calliditas is also supported by its Scientific Steering Committee, a highly regarded network of leading experts, that serve as external advisors and investigators on clinical trials.